EPA Cracks Down on Public Health Claims, Product Efficacy

The Environmental Protection Agency (EPA) has been cracking down on unapproved disinfectant products and unsubstantiated claims. One of the latest occurred in November 2009 when the EPA issued a warning about unscrupulous vendors who may market ineffective and unregistered products or services that claim to disinfect surfaces or entire rooms against the H1N1 influenza virus. The EPA registers disinfectants for use on hard surfaces, and when used according to label directions, such products will be effective against influenza A viruses, including the 2009 H1N1 pandemic strain. There are no products registered by EPA for use in residential settings that will disinfect or sterilize the air or a room by fogging. Claims for disinfecting carpeting, drapes and other porous surfaces are also false. The products approved by EPA are for use on hard surfaces only, and the label must state that the product is registered for the influenza A virus.

In October 2009, Samsung was fined $205,000 for making claims that its keyboards were antimicrobial and inhibited germs. According to the EPA, Samsung had not registered its products with the agency and was found to be in violation of the federal pesticide law. Samsung agreed to pay the fine and to stop making the claims; these claims on the company’s labels and promotional material for netbook and notebook computer laptops would render the products pesticides, requiring registration by EPA. And in 2008, the EPA fined ATEN Technology, Inc. $208,000 for “nano coating” pesticide claims on computer peripherals. The EPA maintained that IOGEAR made unsubstantiated public health claims regarding unregistered products, and their ability to control pathogens, a violation of the Federal Insecticide, Fungicide and Rodenticide Act. IOGEAR products at issue were: wireless laser mouse with nano shield coating, laser travel mouse with nano coating technology, and wireless RF keyboard and mouse combinations. After being contacted by EPA, IOGEAR stopped making claims that their computer peripherals protect against germs.

“We’re seeing far too many unregistered products that assert unsubstantiated antimicrobial properties,” says Katherine Taylor, associate director of the Communities and Ecosystems Division in EPA’s Pacific Southwest region. “Whether the claim involves use of an existing material such as silver, or new nano technology, the EPA takes these unverified public health claims very seriously. Consumers should always follow common-sense hygiene practices, like washing hands frequently and thoroughly.”

“Pesticides can be beneficial in killing off harmful bacteria, but they can also be dangerous if they don’t work as claimed,” says George Pavlou, acting regional administrator at the EPA. “Members of the public think their health is being protected when it actually is not. Making sure that public health claims are true is part of the reason EPA governs the use of pesticides, and it is absolutely essential that those using pesticides register with EPA so that the agency can ensure the safety of all involved.”

EPA’s federal pesticide law, also known as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), is designed to regulate the sale and use of pesticides in the United States. Before a pesticide can be sold or distributed in the United States, FIFRA requires that registration be obtained from the EPA. In making a registration decision, the EPA must determine that the pesticide, when used in accordance with labeling directions, will not cause unreasonable adverse effects to human health or the environment. Without a pesticide product in its registration database, the EPA cannot, for example, prescribe labeling requirements that set forth effective warnings and specific directions for use.

A related effort by the EPA has been the ongoing process of confirming the efficacy of hospital disinfectants. The Antimicrobial Testing Program (ATP) was initiated in response to findings presented by the Government Accounting Office (GAO) which indicated that the EPA lacked assurance that antimicrobial products registered by the agency were efficacious. The EPA has focused its efforts on evaluating registered products that are most crucial to infection control, such as sterilants, tuberculocides and hospital-level disinfectants. ATP implementation provides increased assurance antimicrobial products used in hospital settings are efficacious potentially reducing the incidence of nosocomial infections. Chemical disinfection of hard, non-porous surfaces such as floors, bed rails and tables is recognized as one component of the infection control systems in hospitals, food processing operations and other places where disease-causing microorganisms such as bacteria and viruses may be introduced or present. Other measures such as frequent handwashing, waste disposal and sterilization of instruments and devices are examples of other practices critical to infection control.

Through its ATP, the EPA collects and tests samples from manufacturers or other places. The efficacy test methods provide a rigorous challenge to the product, as the level of bacteria used in the test(s) is at least 1,000 times greater than the contamination level typically found on surfaces in healthcare facilities. This high standard was adopted by the EPA to ensure that products will be effective even when extremely high pathogen levels are present. The current focus of testing is on the “primary” registration of each disinfectant product formulation. The manufacturers of these primary registered products often contract with distributors, who then register products with identical formulas. Results of the testing program currently show that approximately two-thirds of the hospital disinfectants and half of the tuberculocides are fully efficacious when challenged at the highest bacterial challenge level. Those that have not met this high standard are brought into compliance through regulatory or enforcement measures, or a combination of both. The registrant may be required to reformulate, reduce the product claims, change the use directions or even cancel the product.

Products tested through the ATP include approximately 325 hospital disinfectants and 72 tuberculocides. Disinfectant products with public health claims must be effective against both Staphylococcus aureus and Pseudomonas aeruginosa to meet EPA registration efficacy standards for use as a hospital disinfectant. Tuberculocidal products must also be effective against Mycobacterium bovis BCG. Approximately two-thirds of the tested hospital disinfectant products and half of the tuberculocidal products have met EPA’s post-registration efficacy standards. If a product does not meet post-registration efficacy standards under the ATP, EPA will determine the appropriate action to be taken. Options used individually or in combination to bring the product into compliance include: reformulation of the product and retesting by the manufacturer; removal of hospital disinfectant or tuberculocidal claims from the product’s label; modification of label directions (such as contact times) and retesting by the manufacturer following the new directions; voluntary cancellation of the product by the manufacturer; and EPA initiates removal of the product from the marketplace.

When the ATP was initiated in 1991, three categories of antimicrobial products were identified for post-registration evaluation: tuberculocides, hospital disinfectants and sterilants. These products were selected because health care facilities use them to reduce the number of microorganisms on hard, nonporous surfaces as part of their infection control program. EPA is currently in the process of testing antimicrobial products with tuberculocidal and hospital disinfection claims. Sterilant testing was completed in 1993. In 1996, regulatory authority for certain liquid chemical sterilant products was transferred to the Food and Drug Administration under the Food Quality Protection Act amendments to FIFRA.

For the purpose of product registration, the EPA accepts specific methods for testing the effectiveness of hospital disinfectants and tuberculocides. The majority of methods are maintained and published by Association of Analytical Chemists (AOAC) International, a standard-setting organization. These same methods are used for post-registration evaluation in the ATP. The challenge microorganisms used to determine the effectiveness of hospital disinfectants are Staphylococcus aureus and Pseudomonas aeruginosa, and for tuberculocides, Mycobacterium bovis BCG. Read more about EPA’s standard operating procedures for ATP testing. The EPA has established the end of 2011 as the goal for completing the post-registration evaluation of efficacy of the remaining hospital disinfectants and tuberculocides under the ATP. In addition, EPA is developing an ATP strategy that includes continued oversight of primary and distributor products. The strategy and implementation plan are scheduled to be completed in early 2010 and will be publicly available.

Every pesticide must have labeling which is accepted by EPA before the pesticide can be sold or distributed. As defined in FIFRA Section 2(q)(1)(A), a pesticide is misbranded if its labeling bears any statement, design or graphic representation which is false or misleading. FIFRA Section 12(a)(1)(E) provides that it is unlawful for any person to distribute or sell any pesticide which is misbranded. According to the EPA, examples of statements that are considered to be misbranded include a false or misleading statement concerning the composition of the product; a false or misleading statement concerning the effectiveness of the product as a pesticide or device (EPA may review and approve or disapprove non-pesticidal claims appearing on a pesticide label); a false or misleading statement about the value of the product for purposes other than as a pesticide or device; a false or misleading comparison with other pesticides or devices; or any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by an agency of the federal government;a true statement used in such a way to give a false or misleading impression to the purchaser; and label disclaimers or warranty statements which negate or detract from labeling statements required under FIFRA and EPA’s regulations.

Some examples of unacceptable claims include statements that imply or suggest that the product can or will prevent or control disease or offer health protection. Claims such as “prevents infection,” “controls infection” or “prevents cross infection” or that the product will control or mitigate any disease, infection or pathological conditions constitute public health claims and are not acceptable according to the EPA.

Even though registrants/applicants must conduct efficacy studies, the EPA only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data when a pesticide product bears a claim to control pest organisms that pose a threat to human health, including microorganisms which are infectious to man in any area of the inanimate environment. The EPA encourages practitioners who evaluate products for the healthcare environment to keep these points in mind when reviewing labels bearing public health efficacy claims: The terms “microbiocide,” “microbicide” and “microbiostat” generally are not acceptable on a public health product. If used on a non-public-health product, the claim must be qualified to indicate that the product does not provide public health protection. The term “biocide” generally is unacceptable on a public health product because it implies that the product can kill all living organisms. It may be used on a non-public-health product provided it is qualified by directions for use or other statements that make clear the types of organisms to be controlled. Terms which describe a specific level of efficacy and which are standard EPA-accepted claims such as “bacteriostatic,” “sanitizer,” “disinfectant” and “sterilant” are acceptable when data supports their use. Terms which function only to define a use site and which are not themselves claims of heightened efficacy, provided that such terms are not used in a manner that is misleading, are acceptable. For example, “hospital use” may be acceptable as long as it doesn’t imply “hospital strength,” is not used in the product name and is not highlighted on the label to the exclusion of other acceptable use sites. Claims that are inconsistent with efficacy established by testing are unacceptable. For example, a claim of 30-second efficacy is not acceptable if testing and/or use directions require two-minute contact time for efficacy. Claims of efficacy based on an unsubstantiated, or improbable site/pest relationship are unacceptable; for example, a claim for control of Legionnaire’s disease in cooling tower water is unacceptable.

As we have seen, antimicrobial coatings are considered to be treated articles, which, according to the EPA, typically refer to articles or substances which are impregnated with, or have antimicrobial pesticide incorporated into them, to protect the articles or substances themselves. Incorporation or impregnation usually occurs during manufacture of the article; however, it also can occur after manufacture but prior to use of the article. According to the EPA, most efficacy claims for treated articles are considered “residual” because efficacy can occur over an extended time period; whereas efficacy claims for non-treated articles are considered “non-residual” since efficacy usually occurs over a shorter time period. “Non-treated articles” refer to articles, surfaces, or other inanimate objects which are not impregnated with, or have antimicrobial pesticide incorporated into them during, or after, manufacture. These inanimate objects, which include hard, non-porous surfaces, typically are treated with the more conventional antimicrobial pesticides (e.g., sanitizing sprays, sanitizing rinses). “Antimicrobial” means the property of any pesticide to prevent, destroy, or mitigate any bacteria, pathogenic fungi, or viruses in any environment except those on or in living man or other animals; those on or in living plants or the substrate in which they grow; and those on or in processed food, beverages or pharmaceuticals. Antimicrobial products include sterilizers, disinfectants, virucides, tuberculocides, algicides, sanitizers, bacteriostats, and fungicides used against fungi that are pathogenic for man or other animals. The term “antimicrobial” is too general to meaningfully describe a specific level of antimicrobial activity, according to the EPA. “Sanitizer” means an agent that reduces contaminants in the inanimate environment to levels considered safe as determined by Public Health Ordinance, or that reduces the bacterial population by significant numbers where public health requirements have not been established. Sanitizers meeting public health ordinance requirements are generally used on food contact surfaces and are recognized as sanitizing rinses. “Residual self-sanitizing activity of dried chemical residues on hard-inanimate surfaces” typically refers to significant reduction in numbers of infectious microorganisms which may be present or subsequently deposited on treated surfaces that are likely to become and remain wet under normal conditions of use; or to surface chemical residues which occur when the antimicrobial pesticide, which has been incorporated into the treated article, leaches to the surface of the treated article. “Impregnated self-sanitizing fabrics and textiles” typically refer to: fabrics and textile materials, treated with an antimicrobial pesticide during the manufacturing process, to provide durable residual self-sanitizing activity (e.g., significant reduction in numbers of infectious microorganisms which may be subsequently deposited on the finished item) in the presence of moist or wet contamination; and impregnation of chemical residues into the fabric and textile, but impregnation which likely results in surface chemical residues when the impregnated chemical leaches to the surface of the (treated) article. “Bacteriostat” means an agent that inhibits the growth of bacteria in the inanimate environment in the presence of moisture, and in so doing, may or may not affect the viability of organisms.

The EPA registers both public health and non-public health antimicrobial pesticide products. Public health pesticide products include all antimicrobial products intended to control microorganisms infectious for man in any area of the inanimate environment where these microorganisms may present a hazard to human health. For these products efficacy test data are required to be submitted to support registration. Antimicrobial products which fall in the public health area include (but are not limited to) uses that: sterilize, disinfect, and sanitize. However, relative to “treated articles” and public health uses, only sanitizing claims (i.e., residual, self-sanitizing) are appropriate and apply. For non-public health antimicrobial pesticide products (e.g., control of odor-causing bacteria), the EPA does not require submission of efficacy data. However, the registrant is still responsible for ensuring that these products perform as intended by developing efficacy data which must be kept on file. The EPA still has the responsibility of making sure that the use directions proposed for non-health related claims are appropriate and adequate. Therefore, the EPA retains the option of requiring the submission of efficacy data for non-health related claims, should a product or the use directions on the proposed label on a product pose reasonable doubt as to its efficacy as a non-public health related antimicrobial product. Antimicrobial products which fall in the non-public health area include preservation and bacteriostatic claims - that is, uses which control or inhibit: odor-causing bacteria; bacteria causing spoilage, deterioration, or fouling of materials such as paint or industrial fluids (i.e., preservation of materials); and microorganisms infectious only for animals, where product failure against the specified pests would not have human health consequences. However, relative to “treated articles” and non-public health uses, only uses which control odor-causing bacteria or bacteria causing spoilage, deterioration, or fouling of materials (i.e., preservation) are appropriate and apply.

Reference:

U.S. Environmental Protection Agency (EPA). Antimicrobials Divison 2009 Workplan. Feb. 17, 2009.